Faculty Bibliography

We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed. We examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable populations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues.

INTRODUCTION: We sought to evaluate the caliber of education mainstream media provides the public about brain death. METHODS: We reviewed articles published prior to July 31, 2015 on the most shared/heavily trafficked mainstream media websites of 2014 using the names of patients from two highly publicized brain death cases, 'Jahi McMath' and 'Marlise Munoz.' RESULTS: We reviewed 208 unique articles. The subject was referred to as being 'alive' or on 'life support' in 72% (149) of the articles, 97% (144) of which also described the subject as being brain dead. A definition of brain death was provided in 4% (9) of the articles. Only 7% (14) of the articles noted that organ support should be discontinued after brain death declaration unless a family has agreed to organ donation. Reference was made to well-known cases of patients in persistent vegetative states in 16% (34) of articles and 47% (16) of these implied both patients were in the same clinical state. CONCLUSIONS: Mainstream media provides poor education to the public on brain death. Because public understanding of brain death impacts organ and tissue donation, it is important for physicians, organ procurement organizations, and transplant coordinators to improve public education on this topic

OBJECTIVE: We sought to evaluate how neurologists approach situations in which families request prolonged organ support after declaration of death by neurologic criteria (DNC). METHODS: We surveyed 938 members of the American Academy of Neurology (AAN) who treat critically ill patients, including 50% who practice in states with accommodation exceptions (states that require religious or moral beliefs to be taken into consideration when declaring death or discontinuing organ support: California, Illinois, New Jersey, New York), and 50% who practice in nonaccommodation states. RESULTS: The survey was completed by 201/938 individuals (21% response rate), 96 of whom were from accommodation states and 105 of whom were from nonaccommodation states. Both groups reported encountering situations in which families requested continuation of organ support after DNC (48% from accommodation states and 46% from nonaccommodation states). In a hypothetical scenario where a request is made to continue organ support after DNC (outside of organ donation), 48% of respondents indicated they would continue support due to fear of litigation. In reply to an open-ended question, respondents requested that the AAN generate guidelines and advocate to codify laws regarding organ support after DNC, and to improve public and physician education on DNC. CONCLUSIONS: Our findings suggest that it is relatively common for neurologists who treat critically ill patients to encounter families who object to discontinuation of organ support after DNC at some point during their career. It would be beneficial for physicians, families, and society to rely on clear medicolegal guidelines on management of this situation.

In July 2013, the New York State Department of Health passed a regulation requiring that all personnel working in healthcare facilities be vaccinated against influenza or wear a protective mask. This law, however, did not include dental professionals working outside of healthcare settings, such as in a private dental office. It can be argued that dentists are at even higher risk for contracting the flu because they are in close contact with aerosolized particles. With this in mind, a survey was created for members of the New York State Dental Association (NYSDA) to assess the number of dentists voluntarily receiving the annual influenza vaccine, as well as office hygiene practices and attitudes towards mandates of the vaccine. The results indicated that NYSDA dentists do not regularly receive the annual influenza vaccine, nor do they always wear barrier masks while in the presence of patients. Dentists can reduce their role as a nidus for influenza by receiving the influenza vaccine and encouraging staff members to follow suit.

The United States health-care expenditure is rising precipitously. The Congressional Budget Office has estimated that, in 2025, at our current rate of increased spending, 25% of the gross domestic product will be allocated to health care. Our per-capita spending on health care also far exceeds that of any other industrialized country. Health-care costs must be addressed if our country is to remain competitive in the global marketplace and to maintain its financial solvency. If unchecked, the uncontrolled rise in health-care expenditures will not only affect our capacity to provide our patients with high-quality care but also threaten the ability of our nation to compete economically on the global stage. This is not hyperbole but fiscal reality.As physicians, we are becoming increasingly familiar with the economics impacting health-care policy. Thus, we are in a unique position to control the cost of health care. This includes an increased reliance on creating and adhering to evidence-based guidelines. We can do this and still continue to respect the primacy of patient welfare and the right of patients to act in their own self-interest. However, as evidenced by the use of high-volume centers of excellence, each strategy adapted to control costs must be vetted and must be monitored for its unintended ethical consequences.The solution to this complex problem must involve the input of all of the health-care stakeholders, including the patients, payers, and providers. Physicians ought to play a role in designing and executing a remedy. After all, we are the ones who best understand medicine and whose moral obligation is to the welfare of our patients.

Physicians engage in risk stratification as a normative part of their professional duties. Risk stratification has the potential to be beneficial in many ways, and implicit recognition of this potential benefit underlies its acceptance as a cornerstone of the medical profession. However, risk stratification also has the potential to be harmful. We argue that 'profiling' is a term that corresponds to risk stratification strategies in which there is concern that ethical harms exceed likely or proven benefits. In the case of risk stratification for health goals, this would occur most frequently if benefits were obtained by threats to justice, autonomy or privacy. We discuss implications of the potential overlap between risk stratification and profiling for researchers and for clinicians, and we consider whether there are salient characteristics that make a particular risk stratification algorithm more or less likely to overlap with profiling, such as whether the risk stratification algorithm is based on voluntary versus non-voluntary characteristics, based on causal versus non-causal characteristics, or based on signifiers of historical disadvantage. We also discuss the ethical challenges created when a risk stratification scheme helps all subgroups but some more than others, or when risk stratification harms some subgroups but benefits the aggregate group.